Browse recalls
Issuing authority: US FDA — Medical Devices
- 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS 3 Pulse angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS Pulse angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia Moveo angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS 5 Pulse angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS 7 Pulse angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass I
Automated Impella Controller (AIC); Product Code: 0042-0000-US; - 2026-04-16 · US FDA — Medical DevicesClass II
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Produ - 2026-04-15 · US FDA — Medical DevicesClass II
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. - 2026-04-14 · US FDA — Medical DevicesClass II
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): - 2026-04-14 · US FDA — Medical DevicesClass II
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153. - 2026-04-13 · US FDA — Medical DevicesClass II
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577 - 2026-04-10 · US FDA — Medical DevicesClass I
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151 - 2026-04-10 · US FDA — Medical DevicesClass I
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I - 2026-04-10 · US FDA — Medical DevicesClass I
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272- - 2026-04-10 · US FDA — Medical DevicesClass I
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152 - 2026-04-10 · US FDA — Medical DevicesClass II
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P - 2026-04-08 · US FDA — Medical DevicesClass II
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following device - 2026-04-06 · US FDA — Medical DevicesClass II
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m - 2026-04-06 · US FDA — Medical DevicesClass II
INZONE DETACHMENT SYSTEM, REF: M00345100950 - 2026-04-02 · US FDA — Medical DevicesClass I
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S - 2026-04-01 · US FDA — Medical DevicesClass II
i-STAT G3+ cartridge; List Number: 03P78-26; - 2026-04-01 · US FDA — Medical DevicesClass II
i-STAT EG7+ cartridge; List Number: 03P76-25; - 2026-03-31 · US FDA — Medical DevicesClass II
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap - 2026-03-30 · US FDA — Medical DevicesClass II
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 - 2026-03-30 · US FDA — Medical DevicesClass II
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versio - 2026-03-27 · US FDA — Medical DevicesClass I
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 - 2026-03-25 · US FDA — Medical DevicesClass III
Heraeus, PALAMIX uno. Material Number: 66057893. - 2026-03-25 · US FDA — Medical DevicesClass I
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 - 2026-03-25 · US FDA — Medical DevicesClass III
Heraeus, PALAMIX duo. Material Number: 66057897. - 2026-03-25 · US FDA — Medical DevicesClass II
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 - 2026-03-23 · US FDA — Medical DevicesClass II
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: - 2026-03-23 · US FDA — Medical DevicesClass II
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; - 2026-03-19 · US FDA — Medical DevicesClass I
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA - 2026-03-19 · US FDA — Medical DevicesClass I
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo - 2026-03-19 · US FDA — Medical DevicesClass I
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as - 2026-03-19 · US FDA — Medical DevicesClass II
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended - 2026-03-18 · US FDA — Medical DevicesClass II
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. - 2026-03-17 · US FDA — Medical DevicesClass II
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; - 2026-03-16 · US FDA — Medical DevicesClass II
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline - 2026-03-16 · US FDA — Medical DevicesClass II
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL - 2026-03-16 · US FDA — Medical DevicesClass II
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE - 2026-03-16 · US FDA — Medical DevicesClass II
Access Total T4 Calibrator, Catalog No. 33805 - 2026-03-16 · US FDA — Medical DevicesClass II
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV - 2026-03-16 · US FDA — Medical DevicesClass II
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T - 2026-03-16 · US FDA — Medical DevicesClass II
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 - 2026-03-13 · US FDA — Medical DevicesClass II
LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following mater - 2026-03-13 · US FDA — Medical DevicesClass II
(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; - 2026-03-13 · US FDA — Medical DevicesClass II
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following mat - 2026-03-12 · US FDA — Medical DevicesClass I
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 - 2026-03-12 · US FDA — Medical DevicesClass II
iLet Bionic Pancreas, REF: BB1001 - 2026-03-12 · US FDA — Medical DevicesClass II
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor - 2026-03-12 · US FDA — Medical DevicesClass II
ARTIS Pheno VE30A and VE40A, Model 10849000 - 2026-03-11 · US FDA — Medical DevicesClass II
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f - 2026-03-11 · US FDA — Medical DevicesClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 - 2026-03-11 · US FDA — Medical DevicesClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A - 2026-03-10 · US FDA — Medical DevicesClass II
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US - 2026-03-10 · US FDA — Medical DevicesClass II
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. - 2026-03-09 · US FDA — Medical DevicesClass II
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS i - 2026-03-09 · US FDA — Medical DevicesClass II
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system - 2026-03-07 · US FDA — Medical DevicesClass II
Philips Spectral CT on Rails. Model Number: 728334. - 2026-02-27 · US FDA — Medical DevicesClass II
SIGNA Premier systems - 2026-02-27 · US FDA — Medical DevicesClass II
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/ - 2026-02-23 · US FDA — Medical DevicesClass II
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; - 2026-02-20 · US FDA — Medical DevicesClass II
Radius VSM ECG pre-connected Set, REF: 4842, 4695 - 2026-02-20 · US FDA — Medical DevicesClass II
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 - 2026-02-18 · US FDA — Medical DevicesClass I
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd - 2026-02-16 · US FDA — Medical DevicesClass II
THORACIC ROBOTS, DYNJ908777B - 2026-02-16 · US FDA — Medical DevicesClass II
Airway Exam Kit, DYKE1796 - 2026-02-16 · US FDA — Medical DevicesClass II
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K - 2026-02-16 · US FDA — Medical DevicesClass II
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ9 - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 620G Insulin Pump (MMT-1750) - 2026-02-13 · US FDA — Medical DevicesClass I
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm Insulin Pump (MMT-712, MMT-715) - 2026-02-13 · US FDA — Medical DevicesClass I
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) - 2026-02-13 · US FDA — Medical DevicesClass II
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCH - 2026-02-13 · US FDA — Medical DevicesClass I
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B - 2026-02-13 · US FDA — Medical DevicesClass II
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC - 2026-02-13 · US FDA — Medical DevicesClass I
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96 - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 530G Insulin Pump (MMT-551, MMT-751)